CN103610661A - 一种组合物 - Google Patents
一种组合物 Download PDFInfo
- Publication number
- CN103610661A CN103610661A CN201310616628.XA CN201310616628A CN103610661A CN 103610661 A CN103610661 A CN 103610661A CN 201310616628 A CN201310616628 A CN 201310616628A CN 103610661 A CN103610661 A CN 103610661A
- Authority
- CN
- China
- Prior art keywords
- syr
- mannitol
- magnesium stearate
- silicon dioxide
- microcrystalline cellulose
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000203 mixture Substances 0.000 title claims description 13
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 44
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 34
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 22
- 239000011248 coating agent Substances 0.000 claims abstract description 20
- 238000000576 coating method Methods 0.000 claims abstract description 20
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 19
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract description 19
- 229930195725 Mannitol Natural products 0.000 claims abstract description 19
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 19
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims abstract description 19
- 239000000594 mannitol Substances 0.000 claims abstract description 19
- 235000010355 mannitol Nutrition 0.000 claims abstract description 19
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 19
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 19
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 19
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 17
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 16
- 239000007916 tablet composition Substances 0.000 claims abstract description 12
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims abstract description 10
- 239000000843 powder Substances 0.000 claims abstract description 9
- 229920002785 Croscarmellose sodium Polymers 0.000 claims abstract description 8
- ZSBOMTDTBDDKMP-OAHLLOKOSA-N alogliptin Chemical compound C=1C=CC=C(C#N)C=1CN1C(=O)N(C)C(=O)C=C1N1CCC[C@@H](N)C1 ZSBOMTDTBDDKMP-OAHLLOKOSA-N 0.000 claims description 37
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 16
- 238000002360 preparation method Methods 0.000 claims description 12
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 9
- 238000004132 cross linking Methods 0.000 claims description 9
- 229950005770 hyprolose Drugs 0.000 claims description 9
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 9
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 9
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 claims description 7
- 230000001476 alcoholic effect Effects 0.000 claims description 6
- 238000002156 mixing Methods 0.000 claims description 5
- 238000002203 pretreatment Methods 0.000 claims description 4
- 229960001855 mannitol Drugs 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 9
- 238000004519 manufacturing process Methods 0.000 abstract description 5
- 229960000447 alogliptin benzoate Drugs 0.000 abstract description 4
- KEJICOXJTRHYAK-XFULWGLBSA-N alogliptin benzoate Chemical compound OC(=O)C1=CC=CC=C1.C=1C=CC=C(C#N)C=1CN1C(=O)N(C)C(=O)C=C1N1CCC[C@@H](N)C1 KEJICOXJTRHYAK-XFULWGLBSA-N 0.000 abstract description 4
- 238000005550 wet granulation Methods 0.000 abstract description 4
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 abstract 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 abstract 1
- 238000003825 pressing Methods 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 description 10
- 239000000243 solution Substances 0.000 description 7
- 238000005516 engineering process Methods 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- 238000007906 compression Methods 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- 108010067722 Dipeptidyl Peptidase 4 Proteins 0.000 description 2
- 108010004460 Gastric Inhibitory Polypeptide Proteins 0.000 description 2
- 102100039994 Gastric inhibitory polypeptide Human genes 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000000151 deposition Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 102100025012 Dipeptidyl peptidase 4 Human genes 0.000 description 1
- 102100023915 Insulin Human genes 0.000 description 1
- 108090001061 Insulin Proteins 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- GCYXWQUSHADNBF-AAEALURTSA-N preproglucagon 78-108 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1N=CNC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 GCYXWQUSHADNBF-AAEALURTSA-N 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 238000007613 slurry method Methods 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
检测指标 | 实施例1样品 | 实施例2样品 | 实施例3样品 | 对照例2样品 |
粘冲现象 | 不粘冲 | 不粘冲 | 不粘冲 | 粘冲 |
流动性 | 较好 | 较好 | 较好 | 较差 |
溶出度% | 99.5 | 99.2 | 99.4 | 80.3 |
Claims (5)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201310616628.XA CN103610661B (zh) | 2013-11-22 | 2013-11-22 | 一种组合物 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201310616628.XA CN103610661B (zh) | 2013-11-22 | 2013-11-22 | 一种组合物 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN103610661A true CN103610661A (zh) | 2014-03-05 |
CN103610661B CN103610661B (zh) | 2017-09-12 |
Family
ID=50161396
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201310616628.XA Active CN103610661B (zh) | 2013-11-22 | 2013-11-22 | 一种组合物 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN103610661B (zh) |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101106977A (zh) * | 2005-01-18 | 2008-01-16 | 诺瓦提斯公司 | 直接压片的配方及方法 |
WO2008093878A1 (en) * | 2007-02-01 | 2008-08-07 | Takeda Pharmaceutical Company Limited | Tablet preparation without causing a tableting trouble |
CN102935081A (zh) * | 2005-09-14 | 2013-02-20 | 武田药品工业株式会社 | 用于治疗糖尿病的二肽基肽酶抑制剂 |
CN103156819A (zh) * | 2013-03-29 | 2013-06-19 | 山东罗欣药业股份有限公司 | 苯甲酸阿格列汀组合物片剂及其制备方法 |
-
2013
- 2013-11-22 CN CN201310616628.XA patent/CN103610661B/zh active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101106977A (zh) * | 2005-01-18 | 2008-01-16 | 诺瓦提斯公司 | 直接压片的配方及方法 |
CN102935081A (zh) * | 2005-09-14 | 2013-02-20 | 武田药品工业株式会社 | 用于治疗糖尿病的二肽基肽酶抑制剂 |
WO2008093878A1 (en) * | 2007-02-01 | 2008-08-07 | Takeda Pharmaceutical Company Limited | Tablet preparation without causing a tableting trouble |
CN103156819A (zh) * | 2013-03-29 | 2013-06-19 | 山东罗欣药业股份有限公司 | 苯甲酸阿格列汀组合物片剂及其制备方法 |
Non-Patent Citations (1)
Title |
---|
朱涛 等: "粉末直接压片法制备格列苯脲片及稳定性考察", 《中国医药工业杂志》 * |
Also Published As
Publication number | Publication date |
---|---|
CN103610661B (zh) | 2017-09-12 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C41 | Transfer of patent application or patent right or utility model | ||
CB02 | Change of applicant information |
Address after: 264205, Weihai economic and Technological Zone, Shandong Province, Qingdao South Road, No. 1 Applicant after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Applicant after: Shandong Disha Pharmaceutical Co.,Ltd., Disha Phamaceutical Group Applicant after: WEIHAI DIJIA PHARMACEUTICAL Co.,Ltd. Address before: 264205, Weihai economic and Technological Zone, Shandong Province, Qingdao South Road, No. 1 Applicant before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Applicant before: Shandong Disha Pharmaceutical Co.,Ltd., Disha Phamaceutical Group Applicant before: WEIHAI DIJIA FINE CHEMICAL Co.,Ltd. |
|
COR | Change of bibliographic data | ||
TA01 | Transfer of patent application right |
Effective date of registration: 20160623 Address after: Economic and Technological Development Zone of Shandong Province, Weihai City, Gushan Town, 264400 No. 18 South Road, No. 19 North Road, No. 3 East Road, the west five Applicant after: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. Applicant after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Address before: 264205, Weihai economic and Technological Zone, Shandong Province, Qingdao South Road, No. 1 Applicant before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Applicant before: Shandong Disha Pharmaceutical Co.,Ltd., Disha Phamaceutical Group Applicant before: WEIHAI DIJIA PHARMACEUTICAL Co.,Ltd. |
|
GR01 | Patent grant | ||
GR01 | Patent grant | ||
TR01 | Transfer of patent right |
Effective date of registration: 20191106 Address after: 264205 No. 1 South Qingdao Road, Weihai economic and Technological Development Zone, Shandong, China Co-patentee after: Dijia Pharmaceutical Group Co.,Ltd. Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Co-patentee after: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. Address before: Economic and Technological Development Zone of Shandong Province, Weihai City, Gushan Town, 264400 No. 18 South Road, No. 19 North Road, No. 3 East Road, the west five Co-patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee before: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. |
|
TR01 | Transfer of patent right | ||
TR01 | Transfer of patent right | ||
TR01 | Transfer of patent right |
Effective date of registration: 20210730 Address after: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee after: Dijia Pharmaceutical Group Co.,Ltd. Address before: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee before: Dijia Pharmaceutical Group Co.,Ltd. Patentee before: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. |